Approximately 16.0% of the United States population suffers from Overactive Bladder (OAB). Because OAB is a chronic condition, treatments must be administered on a periodic basis to control the systems. Injections of OnabotulinumtoxinA, marketed under the trade name Botox, have proven effective in treating OAB for longer periods of time with low incidence of adverse events. Current methods of delivering OnabotulinumtoxinA to the bladder involve inserting a cystoscope and needle through the urethra to the bladder and manipulating the entire assembly both laterally and along the axis of the urethra as a unit to inject the medication into the bladder wall. Because the cystoscope and needle are moved together during this procedure, current devices and their methods of use result in significant patient discomfort and possible damage to the urethra.
The placement and pattern of the multiple injections in the bladder are associated with significantly improved treatment outcomes. Thus, it is important that devices and methods of injecting OnabotulinumtoxinA into the bladder offer physicians performing the procedure precise control. However, it is difficult to create precise injection patterns using current devices and methods because the scope moves with the needle when aiming for a new injection site. Moreover, said devices are usually not disposable, and must be disassembled and sterilized after each use, making them difficult to maintain and increasing the risk of contamination or infection.
Endoscopes, more particularly, cystoscopes, are commonly used in injection procedures to visualize the target injection sites on the bladder. In prior art systems, endoscopes are exposed to the bodily fluids of the patient, requiring them to be sterilized after each injection procedure. Proper sterilization of endoscopes requires a process that may take up 48 hours, during which time the endoscope may not be used. Physicians must thus schedule fewer procedures or purchase more endoscopes.
What is needed, therefore, is a device that can inject OnabotulinumtoxinA in precise patterns on the bladder wall while minimizing lateral movement of the device itself while in the urethra to decrease patient discomfort and probability of urethral injury. Furthermore, said device should be simple enough to keep manufacturing costs at a minimum so that the device may be disposable. The device must also isolate endoscopes used in conjunction with the device from the external environment and bodily fluids of the patient without impairing the visual fidelity of the endoscope.